Human Cloning and Human Dignity:
An Ethical Inquiry

Table of Contents

The President's Council on Bioethics
Washington, D.C.
July 2002
www.bioethics.gov

Chapter Seven

Public Policy Options

The connection between moral assessment and public policy, here as elsewhere, is hardly straightforward. The relation of morality to law is notoriously complex, especially in free societies such as our own in which citizens may live their lives according to their own moral views. At the same time, however, practices deemed seriously wrong and harmful are outlawed, from incest and sexual abuse to slavery and racial discrimination. In addition, law functions not only to encourage or discourage conduct but also as a moral teacher. It expresses the social norms of the community, whether by fostering public education and medical research or by discouraging dishonest business practices and teenage pregnancy. Whether and how the law should address any given morally charged topic is often a debatable matter, requiring careful study and prudent judgment. Not everything that is morally defensible should be encouraged by public policy; not everything that is morally troubling should be legally proscribed.

These general remarks apply also to the case at hand. The moral assessments of the previous two chapters do not carry self-evident policy recommendations. Even a thoroughly developed moral position on either or both of the uses of human cloning still leaves open the question of what public policy would be appropriate, prudent, and effective. One can be morally opposed to cloning-to-produce-children, yet also oppose making it illegal, say, because of hesitation to increase the police power of the state in matters of reproduction. Or one can have no personal moral objection to cloning-for-biomedical-research, but still find practical reasons to favor a moratorium on such activity, say, because one wants to develop regulatory institutions before allowing the research to proceed. Moral principle and judgment, though necessary, are not sufficient for deliberating about what to do about human cloning. Prudence is also required.

In this chapter, we consider a broad range of public policy options. We assess and compare these options in the hope of seeing our way clear, in the eighth and final chapter of this report, to offer recommendations that comport, not only with our ethical judgments, but also with our sense as citizens of what is prudent, practical, and appropriate for this country at this time.

The policy debate about human cloning is a particularly vivid example of the tension between competing public goods, between the goods served by biomedical science and technology and other moral and social goods important to community life. The desire to ban human cloning, whether for producing children or for biomedical research, arises primarily from moral and social objections made in the name of human dignity, individuality, and respect for life. The opposition to a comprehensive ban on human cloning arises primarily from a belief that cloning research may lead to new remedies for human diseases and disabilities, backed also by appeals to the principle of freedom for scientific inquiry and technological innovation. Assumptions about the relative merits of these competing goods, as well as about the broader relation between science and society, lie just beneath the surface of this debate. Wittingly or not, these assumptions inform how people think about the various policy options proposed for dealing with human cloning. A brief examination of the more general question of the relation between science and society might clarify the principles that should guide our approach to a national policy on human cloning.

I. Science and Society

Since its birth in the seventeenth century, modern science – and especially modern medicine – has been guided by a desire to improve and elevate the human condition. Unlike ancient science, which sought speculative knowledge of what things are purely as an end in itself satisfying to the knower, modern science from the start sought effective knowledge of how things work, in the service of what Francis Bacon called "the conquest of nature for the relief of man's estate." Since then, scientists have been increasingly motivated not only by a deep desire to know, but also by a desire to do: that is, to provide resources, know-how, and relief in humanity's pursuit of health, happiness, and comfort. Biomedical scientists especially have pursued a dual goal: to increase our knowledge and understanding of living nature and to help the sick and the suffering.

In exchange for the promise of great human benefits, the practice of science entered into an unprecedented relation to the larger society. Scientists gradually acquired a privileged standing in modern societies, first with protections against persecution and censorship, later with public recognition and financial support. But it deserves to be noted that, insofar as the public respect for science rests on its moral intention and its ability to deliver the goods that society wants, scientists tacitly subject themselves to public scrutiny and moral judgment of their work, both as to ends and to means. The tacit social contract between scientists and society – freedom and support for scientists, benefits for all humanity – is double-sided: on the one hand, the opportunity for scientists to be public benefactors and recognized as such; on the other hand, the need, in cases where values conflict, for scientists to defend what they do in terms of the community's judgments about the relation of scientific activity to other moral and social goods.

As we have noted in the previous chapters, in the twentieth century, biomedical science made tremendous advances, resulting in both greater knowledge of how the human body works and greater ability to affect its workings. The results have been so dramatic, and so beneficial, that in the United States today virtually no one questions the benefits of the modern scientific endeavor, especially in medicine. This consensus about benefits has expressed itself as consistently strong public support for public funding of basic research, as well as strong support for the freedom of scientists to set their own research agendas, limited only by their curiosity, their imaginations, and our commonly agreed-upon moral and ethical norms. The tacit "contract" or relationship between science and society recognizes and celebrates the great benefits of freedom for all involved.

But for all these great benefits and good purposes, there are also times when the activities of scientists or the products of scientific work can imperil society and its members. For one thing, the work of scientific research is by its nature experimental. Scientific inquiry involves action, not only observation or theory. For this reason, freedom of inquiry does not adequately describe the freedom that scientific work requires and is generally granted. It may be more accurate to say that scientists desire and often receive great freedom of action. Yet because scientists learn by doing, some of what scientists do can be dangerous or inappropriate. And because some of their actions may infringe on the rights, security, or dignity of individuals, or on the principles and interests of society as a whole, scientific freedom of action cannot be absolute.

In addition, many of the technological products of scientific research can be used to do harm as well as good. Just as society has moved in the past to restrict access to dangerous nuclear and biological agents, as well as to restrict public access to information about these things, so too will society be confronted with moral challenges by the new biomedical technologies. Technologies that disclose our genetic abnormalities or that alter the human genome, neurotropic drugs that can enhance (or destroy) memory or libido, computer implants in human brains – these and many other technological possibilities now on the horizon may raise profound moral and social challenges to privacy, freedom, equality, dignity, and human self-understanding. As citizens we may – indeed we must – decide whether and where to limit potentially harmful research or technology even as we continue to desire and uphold free intellectual inquiry and technological innovation.

American society has done this in the past. The various codes of conduct for human experimentation, discussed at several points in this report, demonstrate some of the ways in which the polity has established important moral boundaries that biomedical researchers must respect. In addition, rules and restrictions governing the pharmaceutical industry, the practice of medicine, the sale of organs for transplantation, the handling of biohazards, the development of biological weapons, and numerous other areas of scientific and technological work show that even given our desire for scientific advance and our belief in the inherent value of freedom, the pursuit of research and technology has not been allowed to trump all other concerns.

Thus we conclude that in the realm of genetics and reproduction, as in many others, boundaries and regulations may be needed: lines may need to be drawn that none may cross, guidelines may need to be established that all must follow. Because the wisdom needed to decide how scientific knowledge and technology should be used is not something that science can provide by itself, these boundaries and regulations must be set by the whole community, democratically, through its representative institutions, and not only by those who are experts in the scientific work involved. Our analysis in Chapters Five and Six of the serious moral and social questions raised by human cloning has persuaded us that human cloning in both its forms is an appropriate area for public policy.

II. Public Policy Options: General Considerations

Having decided that human cloning is an activity fit for public policy decision, we still face many questions. Does it warrant legislative proscription, governmental regulation, professional oversight or self-regulation, or merely civil tort liability for bad results? And how broadly or narrowly should we delimit the domain in which human cloning is to be considered? Although the ethical analysis in this report has often concentrated on human cloning considered on its own, when considering public policy it is especially important to recall the larger contexts in which human cloning belongs. As we emphasized in Chapters One and Two, human cloning (in both its possible uses) would be but a special area of a larger domain of biotechnology, made possible by present and projected techniques of embryo research, assisted reproduction, genetic screening, and genetic engineering – all of which are coming to be grouped under the field of "reprogenetics." As we contemplate possible policy options regarding human cloning, it behooves us to consider what cloning's place within this broader context might mean for public policy.

Many other countries have in fact taken up cloning in this broader context. In Germany, for example, this broader approach has taken the form of a series of legal proscriptions and restrictions, centered on the Embryo Protection Act of 1990. The act treats all embryo research together and prohibits all interventions not undertaken for the well-being of the embryo (including the creation of embryos specifically for research). The German system also includes specific rules for IVF procedures, and in general treats all interventions involving the human embryo under one rubric. Human cloning, for whatever purposes, is legislatively prohibited.

In the United Kingdom, too, policy on these subjects takes as its organizing principle the human embryo itself, though the approach here is regulative rather than proscriptive. The British system is centered around a regulatory body – the Human Fertilization and Embryology Authority (HFEA), created in 1990 – charged with monitoring and regulating essentially all of what has come to be called reprogenetics, including human cloning, both for producing children and for biomedical research. The HFEA regulates infertility treatment and clinical work; storage of gametes and embryos; and all embryo research, whether publicly or privately funded. It licenses these various activities, monitors compliance, sets standards of practice, establishes limits and requirements on the use of embryos for various purposes, and maintains a detailed information registry about both assisted reproduction and embryo research. Human cloning is treated within this broader regulatory scheme: cloning-to-produce-children is not permitted; cloning-for-biomedical-research is allowed, but only with cloned embryos no older than fourteen days.

Canada is completing the process of establishing a national system, combining elements of legal proscription and governmental regulation, to govern all technological activities used to help people have children as well as the use of embryos in research. Some activities would be permitted and regulated, others would be prohibited by law. The chosen point of departure is not the human embryo, but rather the goods of human health and dignity: to protect the health and safety of Canadians; to prevent commercial exploitation of reproduction; and to protect human individuality and diversity and the integrity of the human genome. A single broad regulatory body, the Assisted Human Reproduction Agency of Canada, would issue and renew licenses for assisted reproduction facilities, collect and analyze health information, set policies, and monitor compliance. Among the prohibited activities are all human cloning, whether to produce children or for biomedical research. Human embryos no longer needed for infertility may be used for stem cell research (with consent of the progenitors). But producing in vitro embryos for research purposes is prohibited, except for efforts to improve assisted reproduction procedures.1

Several other countries have approached this area of biotechnology with a similar broad outlook. The United States to date has not; indeed we lack any national monitoring, oversight, or regulatory system in this area. It may therefore be appropriate, in connection with thinking about specific policies for human cloning in the United States, to initiate discussions of a national policy for these related arenas. Doing so might allow us to regard the question of embryo research in its full scope, and to consider it together with the closely related issues that arise when the techniques of assisted reproduction come together with those of genetic diagnosis and potential genetic engineering. In putting forward its recommendations in the next chapter, the Council will take into account this broader context of related biotechnologies.

Yet, much as it would be desirable to consider public policy regarding human cloning in its larger context, it is for us also necessary to consider it on its own. Owing to the immediate concern over the prospect of cloning-to-produce-children, legislative proposals and public debate have largely treated the subject of human cloning in isolation – though for reasons we have noted, it has overlapped with the controversy about embryonic stem cell research. Accordingly, the policy options presented below are drawn for the most part from the ongoing public and legislative debate about human cloning, and therefore direct themselves to legislative alternatives regarding cloning in particular.

There is a complication that bedevils prospects for legislation regarding human cloning. Given that human cloning may be used for two very different purposes – to produce children and for biomedical research – one might think that these two different uses could be treated independently, just as we have done (for the most part) in the ethical analyses in Chapters Five and Six. The ethical issues of cloning-to-produce-children and cloning-for-biomedical-research differ considerably, and, as our own discussions have indicated, one's moral assessment of the second can be independent of one's moral assessment of the first. Some people who oppose cloning-to-produce-children may favor cloning-for-biomedical-research; some people who oppose producing embryos solely for research may object less forcefully to cloning-to-produce-children (should it ever become safe to attempt it). And people who oppose both uses may differ as to which they think is the worse. Given these variations, it would seem sensible to disaggregate the two forms of cloning and develop independent public policies for each.

But this is easier said than done. The reason is simple: both forms begin in the same way with the act of cloning (by somatic cell nuclear transfer [SCNT]) that produces a cloned human embryo. It is therefore difficult – perhaps impossible – to craft a public policy regarding one use of cloned human embryos that does not, at least tacitly but usually explicitly, also affect the other. A thoroughgoing attempt to prevent cloning-to-produce-children by banning the first step would also prevent cloning-for-biomedical-research. An attempt to promote cloning-for-biomedical-research might well have consequences for cloning-to-produce-children (for example, by improving the technique or by increasing the likelihood of attempts to initiate a pregnancy). An attempt to prevent cloning-to-produce-children at the step of transfer of a cloned embryo to initiate a pregnancy would tacitly approve the initial creation of cloned embryos for other purposes. Moreover, by imposing penalties on implantation while sanctioning creation, a policy that banned only transfer to a uterus would in effect require, by law, that cloned human embryos be destroyed.

Even if one thinks only of the task of statutory drafting, the difficulty persists. For if one wants to make a particular action illegal, one must specify precisely the act to be proscribed. It turns out to be very difficult to specify precisely and unambiguously the forbidden act of human cloning without touching both uses at once. "It shall be unlawful to attempt to clone a human being" is simple enough to say, but vexing to specify. The meaning of the term "human being" is contested: does it mean only a child or adult, or is an embryo too a human being, albeit in its primordial stage? The definition of "to clone" must specify either the initial act of somatic cell nuclear transfer or the birth of a cloned child. "Attempting to clone" will mean either somatic cell nuclear transfer itself or the transfer of the resulting cloned embryo to a woman's uterus.

There is, of course, one possible policy approach that could disentangle the two uses of human cloning, but it would require dealing with cloning-for-biomedical-research in a different context. Since cloning-for-biomedical-research is one form of embryo research – another is research that uses embryos produced by IVF – one could have a broad policy on all embryo research, which would then necessarily apply to research with cloned embryos. Several states have separate laws that cover research on all human embryos, cloned or not. In these cases, a law to deal with the special practice of cloning-to-produce-children could then be added without difficulty. And, as we have indicated, in the United Kingdom and several other countries, there is a broad regulatory system for handling all activities involving human embryos – both for research and for initiating pregnancies – into which further regulations regarding cloned embryos may easily be fit. But the legislative debates in Congress, both in 1998 and in 2001-2002, have not squarely addressed independent treatment of embryo research in general and cloning-for-biomedical-research in particular. That fact shapes our examination of specific public policy options.

III. Public Policy Options: Specific Alternatives

What sort of policy regarding human cloning would be most appropriate in this country at this time? In approaching the various alternatives, we operate on the following premises.

First, given the seriousness of the subject, we favor a policy that makes an explicit and considered decision about whether to proceed. Should our society come to have no rules or guidelines regarding human cloning, it should do so deliberately, not by default.

Second, we need to decide whose decision and responsibility this should be. And while we may differ among ourselves on the answer to this question, we agree that whichever persons, institutions, or agencies of government have authority for the decision and any subsequent oversight, the responsible parties should be answerable to and held accountable by the people and their representatives. This is not an arena where secrecy or lack of accountability should be tolerated.

Third, whether one opts for permission with or without regulation or for legislative proscription, permanent or temporary, we believe that the following two balancing principles should be followed: (1) Because of the gravity of the issues at stake, whoever bears the power of decision needs to be persuaded that we should now proceed with human cloning, in either or both of its forms. (2) At the same time, we should not stand in the way of proceeding simply out of some vague fear of possible future harms of unknown magnitude; we should interfere only if the harms are deemed serious, important to the common good, and likely to occur.

We begin, as we should in America, by examining human cloning in the context of our constitutional system and, in particular, of our special form of federalism. In short, we must consider which level of government has jurisdiction. Human cloning is not obviously a federal concern, nor is it plainly outside the jurisdiction of the states; thus it might be presumed to be a matter for regulation by the states alone. Certainly a number of states have moved to legislate in this area. As of this writing, twenty-two state legislatures have considered bills on cloning, and six of them have passed laws on the subject. Of these, five directly or indirectly prohibit both forms of human cloning, while one prohibits only cloning-to-produce-children.i It is possible to argue that human cloning is one of those many issues, essentially local in nature, that call more or less exclusively for the exercise of local self-government, which in the American system means primarily government by the states. And yet, a number of factors point to the need to consider a federal policy as well.

For one thing, as we hope the foregoing chapters have made clear, human cloning-to-produce-children has nationwide implications, with potentially profound effects on individuals, families, and all of society. This view is reflected in the efforts in Congress to legislate on the subject, first in 1998 and again in 2001 and 2002. President Clinton made clear, in his executive order on human cloning,2 that he regards it as a federal issue; and President Bush has done likewise in several public statements.³

For another thing, the federal government plays an extensive role in funding and regulating scientific research. Insofar as there has been a role for government in the oversight of scientific work in America, it has generally been filled by the federal government, for reasons of scale and efficacy and also to some extent of historical accident. So long as this remains the case, questions relating to the funding and regulation of human cloning will, in practice, be addressed mostly or even solely at the federal level.

Moreover, it can be assumed that, if they remain legally permissible, both forms of human cloning would tend to enter into interstate commerce, thus bringing them within the purview of Congress, at least as far as its power to regulate interstate commerce allows.

Historically, when several or most of the states have proscribed some activity they regard as injurious to public health, safety, or morals (such as prostitution or the use of narcotic drugs), the federal government has tended to enact laws supportive of the states', or most of the states', moral proscriptions, either by restricting interstate commerce (as in the Mann Act relating to prostitution) or even by directly prohibiting the activity itself (as in the Federal Controlled Substances Act). Since the states have begun to act on human cloning, it has become valid therefore to ask whether federal legislation is also needed.

Finally, human cloning has become a subject of international law. A number of nations have moved to prohibit one or both forms of human cloning, and the United Nations is currently debating whether to promulgate an international convention to ban cloning-to-produce-children. Since only the federal government can make treaties or conduct foreign policy for the whole nation, it seems likely that at some point the United – and not merely the separate – States will be under pressure to legislate on this subject.

For some or all of these reasons, we think it reasonable to conclude that human cloning, of either variety, is a fit subject for debate and action at the federal level.ii

With respect to each form of human cloning, cloning-to-produce-children and cloning-for-biomedical-research, there are two basic alternatives: permit or prohibit. For each of these alternatives, there are again two further possibilities: permit with or without regulation; prohibit indefinitely ("ban") or for a limited time ("moratorium"). (The alternative "permit with regulation" might or might not make permission contingent upon getting the regulatory system in place beforehand.) Among the numerous permutations and possibilities, we now take up seven basic policy options that have been publicly discussed and that appear to us worthy of consideration:

• Policy Option 1: Professional self-regulation with no legislative action ("self-regulation").
  
  
• Policy Option 2: A ban on cloning-to-produce-children, with neither endorsement nor restriction of cloning-for-biomedical-research ("ban plus silence").
  
  
• Policy Option 3: A ban on cloning-to-produce-children, with regulation of the use of cloned embryos for biomedical research ("ban plus regulation").
  
  
• Policy Option 4: Governmental regulation, perhaps by a new federal agency, with no legislative prohibitions ("regulation of both").
  
  
• Policy Option 5: A ban on all human cloning, whether to produce children or for biomedical research ("ban on both").
  
  
• Policy Option 6: A ban on cloning-to-produce-children, with a moratorium, or temporary ban, on cloning-for-biomedical-research ("ban plus moratorium").
  
  
• Policy Option 7: A moratorium, or temporary ban, on all human cloning, whether to produce children or for biomedical research ("moratorium on both").

In considering each of these options, we bear in mind four basic questions: (1) How would the policy be enforced and by whom? (2) On what moral opinions, and on what views of the role of government, is it based? (3) What are the arguments in favor? (4) What are the possible objections? To avoid needless repetition, where two options are very similar we refrain from repeating the same arguments at great length, and instead focus on the major new points worthy of note.

This option would enact no new legal restraints on human cloning, and rely instead on self-regulation and private decision making. Passing no law on the subject would maintain the legal status quo; it would leave in place the existing moratorium on federal funding for either form of human cloning, while also leaving private parties free to use private funds to conduct either form of human cloning, as they see fit, consistent with state law.

This approach would let physicians and patients decide privately whether to engage in cloning-to-produce-children 3 It would rely upon the people actually engaged in cloning-for-biomedical-research to establish a mechanism for self-regulation and to prevent abuses. And it could utilize tort liability to deter tragedies and mishaps, by holding people legally responsible for harms inflicted upon a cloned child or his or her mother.

This approach assumes that neither form of human cloning poses moral or practical dangers sufficient to require public action. It assumes that the harms of cloning-to-produce-children are not so grave as to merit a legal restriction, and it sees no harm, or at least negligible harm, in cloning-for-biomedical-research. It also assumes that government's role in regulating scientific research and reproductive medicine should be minimal; that federal legislation may cause more harms than it prevents; that self-regulation provides sufficient safeguards against the worst abuses of cloning practices; that the subject is so complex that the people best qualified to regulate it are the experts in the field themselves; or that any more restrictive policy is unlikely to succeed and likely to drive scientific talent overseas to more permissive jurisdictions.

This hands-off approach would seem to ignore the widespread public and congressional support for a ban on cloning-to-produce-children, as evidenced in the July 31, 2001, vote in the House of Representatives, where nearly every member voted for some kind of federal ban on at least one form of human cloning. Of this option, it may be asked: Is cloning-to-produce-children so morally unproblematic that we could safely leave people free to try it? Would tort liability really be sufficient to deter abuses? And can we afford a laissez-faire policy on what is surely only the first of a series of powerful new genetic technologies? For those who answer "no" to any of these questions, it will be necessary to seek another option.

A second option would be to prohibit cloning-to-produce-children but remain silent on cloning-for-biomedical-research. Such a policy would prohibit the implantation rather than the creation of cloned human embryos. By remaining silent on the question of creating cloned human embryos, this approach would not establish an oversight mechanism or other means of keeping track of cloned embryos or otherwise preventing implantation before the act itself is undertaken. It would therefore probably not require a new enforcement agency; enforcement of the ban would presumably fall to the Department of Justice.

This approach assumes that cloning-to-produce-children is sufficiently unacceptable as to merit legal prohibition, but minimizes or sets aside the disputed question of cloning-for-biomedical-research. It seeks to balance the responsibility for establishing public control over potential misuses of technology with public tolerance for competing worldviews and interests. It permits potentially valuable medical and scientific research to go forward. It preserves the current federal embryo – research policy, which (1) permits all embryo research to proceed unimpeded with private funds, (2) permits research on certain embryonic stem cell lines to proceed under federal guidance with public funds, and (3) leaves open, for continued debate, the question of whether there should be public funding for embryo and embryonic stem cell research.

Against this option, it can be argued that it is not possible for the government to be neutral on the question of cloning-for-biomedical-research. It is difficult, if not impossible, to write a statute banning the act of implanting cloned embryos without tacitly sanctioning the creation of the cloned embryos in the first place. Thus, a ban on cloning-to-produce-children not accompanied by a prohibition on cloning-for-biomedical-research would put the government in the position of allowing the creation of a class of (cloned) human embryos and then effectively mandating their destruction (or at least their perpetual preservation in cold storage), a class of (cloned) human embryos that it would be a felony to try to keep alive to birth. Also such a partial ban could arguably make cloning-to-produce-children more likely to occur. After all, without a regulatory system in place to keep track of and govern the use of cloned human embryos, the ban on implantation would be difficult to monitor and enforce. The commercial production of embryos for research would be protected by industrial secrecy. The transfer of cloned embryos to begin a pregnancy would be virtually undetectable and protected by doctor-patient confidentiality. Those charged with monitoring and enforcing the ban on cloning-to-produce-children would not know who is doing what with cloned human embryos. Moreover, actually enforcing the ban in the event of a violation would be nearly impossible. Once a clonal pregnancy has begun, there would be no real remedy except a forced abortion, an untenable option.

This option would be similar to Option 2 ("ban plus silence"), but in place of silence would require the establishment of a system of oversight and regulation of cloning-for-biomedical-research. These functions would be carried out by a regulatory agency (new or existing) authorized to do some or all of the following things:

1. Establish what may and may not be done with cloned human embryos once they are created, including a prohibition on implantation of cloned human embryos into human, animal, or artificial wombs.
   
   
2. License and conduct prior review of all research involving cloned embryos.
   
   
3. Establish guidelines for the protection of all human subjects participating in the research, including donors of eggs and nuclei.
   
   
4. Register and track each individual cloned human embryo.
   
   
5. Establish the number of days beyond which a cloned human embryo may not be grown in vitro, and enforce this requirement.
   
   
6. Monitor and regulate financial transactions regarding cloned embryos and human oocytes used in cloning-for-biomedical-research.
   
   
7. Monitor corporate, academic, and industrial cloning-for-biomedical-research, check for compliance, and enforce sanctions against violations of regulations.
   
   

   To be effective, such a regulatory structure would have to be applied to both federally funded and privately funded research. Its first purpose would be to facilitate the ban on cloning-to-produce-children, by keeping close track of all research using cloned human embryos. Its second aim would be to enforce certain general standards for the handling and use of cloned human embryos, to ensure that they are not created for frivolous purposes, used irresponsibly, or treated in ways that go beyond what American society deems morally acceptable.

   This option assumes that neutrality on the question of cloning-for-biomedical-research is neither possible nor desirable. Instead, it assumes that a system is needed to regulate and limit the use of cloned embryos – both in the interest of preventing cloning-to-produce-children, and in the interest of establishing a clear ethical framework for undertaking cloning-for-biomedical-research and allowing that research to flourish. At the same time, such a system would establish clear rules and limits to prevent abuses – for example, experimentation on later-stage embryos and fetuses or attempts to produce cloned children.

   This new task could be assigned to an existing regulatory agency (or combination of agencies), such as the Food and Drug Administration or the National Institutes of Health, or, alternatively, it could be carried out by a new regulatory agency devised specifically for the purpose.

   Establishment of a regulatory structure may be aided by the study of models in other countries, such as the United Kingdom's Human Fertilization and Embryology Authority (HFEA) or the Assisted Human Reproduction Agency being brought into existence in Canada – taking into account, of course, the important differences between their political, economic, and health-care systems and our own.

   Regulation, for these proponents, would limit the uses of cloned embryos to especially promising and worthy biomedical research and would set boundaries beyond which such embryos may not be grown or exploited. For some proponents of this option, such oversight and regulation would be aimed primarily at preventing the use of cloned embryos to produce children. For others, regulation is called for to ensure that cloned human embryos be treated not simply as a natural resource but with appropriate measures of respect owed them as humanembryos.

   Against this option can be raised some of the same objections that were raised against Option 2 ("ban plus silence"), namely, that it puts the government in the new position of requiring the destruction of nascent human life, and that it could, by allowing the production of cloned human embryos, make cloning-to-produce-children more likely. It might also be argued against this option that setting up a workable regulatory structure is either impossible or impossible to do very quickly. After all, the IVF and assisted-reproduction industry is today largely unregulated in any way that could be called coordinated, comprehensive, or systematic. The federal government has no experience in regulating or keeping track of the number and fate of embryos produced in IVF clinics.4 And the biotechnology industry has shown little enthusiasm for outside regulation. Establishing an effective regulatory regime could take several years of trial and error, during which time cloned embryos might be mishandled or implanted in an effort to produce children. There are also the dangers that regulatory bodies often prove ineffective and unaccountable and that they are vulnerable to capture by special interests that have a large stake, economic or other, in their regulatory decisions but little incentive to respect the permanent and aggregate interests of the nation. Establishing the regulatory body overseeing human cloning-for-biomedical-research within the National Institutes of Health, for example, would not be reassuring to those who worry that the fate of the embryo will always be subordinated to the imperative for research. In this view, regulation is not enough.

   Policy Option 4: Governmental regulation, perhaps by a new federal agency, with no legislative prohibitions ("regulation of both").

   This option is similar to the regulatory half of Option 3 ("ban plus regulation"), but the regulatory agency would have authority to set policy and guidelines also regarding cloning-to-produce-children. In addition to the functions listed in the description of Option 3, the regulatory body would determine if and when human cloning techniques were sufficiently safe to warrant attempts to produce children by human cloning. The entity might also function as a licensing agency, setting down clear guidelines delineating acceptable and unacceptable purposes for such a practice (for example, it might choose to permit cloning to "replace" a deceased child but not to "replicate" a famous athlete).

   The major argument for this option is flexibility: as the science and technology of human cloning proceeds in nonhuman animals, and as the public's views develop in response to new information and new debates, the nation will not be locked into a legislatively defined position that might later appear to have been misguided. Either a congressional ban or the refusal to enact a ban may prove to be a decision that will later look undesirable and yet difficult to undo.

   Against this option are many of the same objections raised against the regulatory part of Option 3. Also, it may be argued that, given our society's strong moral opposition to cloning-to-produce-children, any decision to permit such a practice, even in exceptional cases, should not be left to a regulatory body; it should rather require a decision by people directly accountable to the voters. This option fails that test.

   Policy Option 5: A ban on all human cloning, whether to produce children or for biomedical research ("ban on both").

   This option would ban the initial act of human cloning – the production of cloned human embryos – regardless of the intended purpose. It would thus prohibit both forms of human cloning.

   Specifically, this approach would proscribe the act of producing cloned human embryos by means of SCNT. Although enforcing the ban would be the responsibility of law enforcement agencies – as would enforcing a ban on cloning-to-produce-children-the "policing of laboratories" would hardly be necessary. Financial and criminal penalties, along with the inability to publish, patent, or profit from (the now illegal) work involving cloned human embryos, would by themselves eliminate nearly all incentive to clone. The ban would deter by subjecting to prosecution and social stigma any researchers or institutions whose efforts to create cloned human embryos came to public attention.

   As we have seen in previous chapters, some proponents of this option argue that the creation, use, and ultimate destruction of cloned human embryos solely for research is morally unacceptable, either in itself or because of its moral consequences. Others hold that a ban only on the transferring of cloned embryos to a woman's uterus, even with additional regulations, would fail to prevent the cloning of a child, and that human cloning must be comprehensively stopped before it starts. Also, any regulatory arrangements that allowed cloning-for-biomedical-research within legally established limits would put the federal government in the novel and morally troubling position of mandating the destruction of nascent life.

   In favor of this approach it can be argued that a "ban on both" would steer scientists toward less morally troubling (and, in the view of some, more medically promising) forms of biomedical research. Indeed, some argue that pursuing cloning-for-biomedical-research might actually hurt those patients whom it claims to help, by diverting valuable resources away from more promising areas of research or more urgent health-care needs. By taking this option, some proponents argue, America would send a strong signal of moral leadership to the rest of the world, where the human cloning question is also currently being debated.

   Against this option it is frequently and vigorously argued that prohibiting cloning-for-biomedical-research would cut off a promising avenue of medical research. It is also argued that forbidding such research here may simply drive American talent overseas and thus diminish American scientific preeminence and economic strength.

   Policy Option 6: A ban on cloning-to-produce-children, with a moratorium, or temporary ban, on cloning-for-biomedical-research ("ban plus moratorium").

   This option would impose a permanent legal prohibition on cloning-to-produce-children, by banning the creation and subsequent transfer of cloned embryos into a woman's uterus. At the same time, it would also prohibit the creation of cloned human embryos for any reason, but would require a mandatory review of that latter prohibition after a certain period of time (for example, five years). This option would lock in a permanent ban on the activity virtually everyone opposes (cloning-to-produce-children), while calling for continued and enlarged debate on a question about which people currently differ (cloning-for-biomedical-research).

   The main benefits of a moratorium on cloning-for-biomedical-research are that it would (1) allow time for research in related fields to proceed and perhaps clarify the potentially unique benefits of cloning-for-biomedical-research or discover superior alternatives that would make cloning-for-biomedical-research unnecessary; (2) allow time for a regulatory structure – whether narrow or broad in scope – to be developed, if deemed desirable; and (3) allow time for further debate and deliberation about the moral questions, to determine if the prohibition on cloning-for-biomedical-research should be renewed, made permanent, or abandoned after the moratorium expires. Rightly understood, a moratorium should not be seen as an attempt to stall, but as an opportunity to figure out the wisest way to proceed. And for those interested in exploring and establishing regulatory arrangements, a moratorium, as a de jure halt, would provide prospective researchers with an incentive (otherwise lacking) to recommend moral and legal guidelines before the moratorium would expire and be up for possible renewal.

   This option separates cloning-to-produce-children from cloning-for-biomedical-research. It therefore would enable policymakers to take up the question of cloning-for-biomedical-research in the larger context of the embryo-research question, rather than in the narrower context of human cloning.

   This option captures much of the current public debate, in which there is general agreement on the need to prohibit cloning for producing children, but a great deal of uncertainty over the proper approach to cloning-for-biomedical-research.

   The arguments against this option are the same as those leveled against Option 5 ("ban on both"), namely, that prohibiting cloning-for-biomedical-research, even for a limited time, would cut off a promising avenue of medical research and simply drive American talent overseas. Others may object that the two uses of human cloning might hereafter be delinked, a prospect that troubles some for both practical and moral reasons (laid out in the discussion of the next option).

   Policy Option 7: A moratorium, or temporary ban, on all human cloning, whether to produce children or for biomedical research ("moratorium on both").

   The final option is a temporary form of Option 5 ("ban on both"), with a mandatory review of the policy after a certain period of time (for example, five years).

   The main benefits of this option are the same as those listed above for Option 6 ("ban plus moratorium"). But this option has what some consider the additional virtue of keeping the two uses of cloning linked in the policy arena. This has, they say, two major benefits.

   First, on practical grounds, the policy on cloning-for-biomedical-research will bear heavily on the feasibility and efficacy of any ban on cloning-to-produce-children, and therefore there is an advantage in ensuring that the two are considered together. Because the availability of cloned embryos would make enforcement of the ban on cloning-to-produce-children more complicated and demanding, a ban on cloning-to-produce-children should never be de-coupled from an identical ban on cloning-for-biomedical-research.

   Second, on moral grounds, some argue that permitting the creation of cloned human embryos for research crosses an important line, and that one use of cloned embryos should not be separated fully from the other in public consideration. They hold that human cloning is a single thing, and therefore should be taken up whole. They are concerned that, at the end of the moratorium outlined in Option 6, the situation would be transformed into Option 2 ("ban plus silence") or Option 3 ("ban plus regulation"), with all the deficiencies that they think these permissive options would hold. For this reason, these opponents argue, it is more appropriate for both forms to be considered together at the end of the moratorium period, even if the eventual resulting policy does not treat them equally.

   Once again, the arguments against this option are the same as those leveled against Option 5 ("ban on both") or Option 6 ("ban plus moratorium") – that it would cut off, at least temporarily, a promising avenue of medical research and drive American talent overseas. In addition, some may object that linking the two uses of cloning misrepresents the state of the public discussion on the subject and places cloning-for-biomedical-research in the wrong context – causing it to be considered always as a form of cloning, rather than as a form of embryo research.

   Finally, some do not want to forgo the present opportunity to enact a permanent ban on cloning-to-produce-children; failure to do so now, they argue, would seem to imply that cloning-to-produce-children may one day be perfectly acceptable.

   * * *

   Having sketched out what we consider to be the most plausible options, we now proceed to offer our own policy recommendations and our reasons for them.

   
   
   

   ENDNOTES

   1. Presentation made by Dr. Patricia Baird, chair, Royal Commission on New Reproductive Technologies, at the June 2002 meeting of the President's Council. Transcript available at the Council's web site, www.bioethics.gov. Back to Text
      
   2. Clinton, W.J., "Memorandum on the Prohibition on Federal Funding for Cloning of Human Beings, March 4, 1997" In Weekly Compilation of Presidential Documents (Volume 33, Number 10), p. 281. Washington, DC: Government Printing Office, 1997. Back to Text
      
   3. Bush, G.W., "Remarks on Human Cloning Legislation, April 10, 2002" In Weekly Compilation of Presidential Documents (Volume 38, Number 15), pp. 608-610. Washington, DC: Government Printing Office, 2002. Back to Text
      
   
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   1. As of June 2002, three states (Iowa, Michigan, and Virginia) ban both cloning-to-produce-children and cloning-for-biomedical-research. Two states (Louisiana and Rhode Island) ban cloning-to-produce-children, but also have embryo-research laws that appear to prohibit cloning-for-biomedical-research. One state (California) has banned cloning-to-produce-children until December 31, 2002, but has no embryo-research law and thus effectively permits cloning-for-biomedical-research. Back to Text
      
   2. We prescind from trying to determine at length whether federal legislation limiting human cloning would infringe on what some believe is a fundamental constitutional right to attempt to procreate. Nor will we try to offer our own legal opinion about whether the Food and Drug Administration has existing authority that would enable it to regulate either or both forms of human cloning. These questions we are content to leave to others. Instead we proceed here on the assumption that, whatever the precise state of the law, Congress may (and we would argue, should) take the lead in determining federal cloning policy. Back to Text
      
   3. The Food and Drug Administration (FDA) has stated that attempts to clone humans would come under its jurisdiction. But this assertion of regulatory authority has never been tested, and might well be disputed if it were invoked in practice. The FDA has never attempted to regulate the human uses of IVF embryos. Back to Text
      
   4. The FDA has never attempted to regulate the practice of IVF, intracytoplasmic sperm injection, preimplantation genetic diagnosis, or embryo research conducted with IVF-produced embryos. Back to Text